The Phase III clinical trial of Prostvac VF (rilimogene galvacirepvec/rilimogene glafolivec) in treatment of metastatic, castration-resistant prostate cancer is now fully enrolled, and initial results of this critical trial are expected within the next 12 months. However, …

It appears that Barvarian Nordic, the developer of Prostvac VF, and its development/marketing partner (Bristol-Myers Squibb) are feeling relatively confident about the potential results of that Phase III trial. Why do we think this? Because a number of new trials have been started that relate to the potential of Prostvac earlier in the disease state.

If you check out the Clinical Trials.gov web site, you will find that all three of the following studies appear to have been initiated in the past 7 months:

5 Responses

These results of trials should be closely held so that drug companies cannot trade on the information nor for future access, marketing and so forth. How do you propose they learned of trial results, so far? Trial validity, ethics, and pharmaceutical economics are at risk.

All I said was that the developers appear to be feeling confident about the potential results. I am quite sure that no one knows what the actual results are yet. There is no way they could. The trial hasn’t reached an endpoint.

On the other hand, lots of people exhibit confidence about outcomes all the time about all sorts of things … on the basis of no data whatsoever.

That’s likely to depend on the quality of the trial results and the speed with which the developer can put together a compelling submission to the FDA.

For the initial approval of enzalutamide, it took the developer about 6 months from time of announcement of the positive trial outcome (on November 2, 2011) to completion of their submission to the FDA (on May 22, 2012). The FDA then stated that they would make a decision about approval by November 2012, but actually issued the formal approval on August 31, 2012 (just 3 months and 9 days later).

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